AIRWAY TECHNOLOGIES, LLC

Airway Technologies, LLC specializes in devices for sleep-disordered breathing and respiratory therapy. Their portfolio includes reusable nasal masks for CPAP/BPAP therapy, such as nasal pillow masks with and without headgear, as well as preformed orthodontic teeth positioners. They also produce mandible-repositioning oral appliances designed to reposition the jaw during sleep to address sleep apnea. These devices are tailored to different patient needs, from modular oral appliance systems to preformed aligners for dental alignment.

Airway Technologies, LLC is based in the United States. This means their devices are subject to U.S. regulatory requirements, including classification under FDA guidelines. Since all their products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with mandatory UDI labeling rules for traceability and transparency in the medical device supply chain.

Airway Technologies, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures standardized identification of medical devices, improving tracking, safety monitoring, and regulatory compliance. This listing helps healthcare providers and regulators verify device details, such as manufacturer information and classification.

Airway Technologies, LLC’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require general controls for regulation, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as outlined in FDA guidelines.

Airway Technologies, LLC’s oral appliances and nasal masks are designed with specific functionalities to address sleep-disordered breathing. Their oral appliances, such as the mandible-repositioning devices, are preformed or modular systems tailored to reposition the jaw, while their nasal masks—like nasal pillow designs—are reusable and optimized for CPAP/BPAP therapy. These distinctions reflect their focus on comfort, customization, and compliance with FDA classification standards for respiratory and dental devices.